Home / Recalls / Paragon 28, Inc. / Z-1468-2022

Z-1468-2022 Class II Ongoing

Recalled by Paragon 28, Inc. — Englewood, CO

Recall Details

Product Type
Devices
Report Date
August 3, 2022
Initiation Date
May 26, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 implants

Product Description

HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

Reason for Recall

Due to Titanium plasma coating not present implant.

Distribution Pattern

U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.

Code Information

Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202

Other recalls by Paragon 28, Inc.

  • Z-0871-2026 Class II — Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S (October 13, 2025)
  • Z-1255-2024 Class II — Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L (December 21, 2023)
  • Z-1256-2024 Class II — Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R (December 21, 2023)
  • Z-1254-2024 Class II — Phantom TTC Nail, 10.0 X 200mm, Right (December 21, 2023)
  • Z-1776-2022 Class II — Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, (July 13, 2022)
  • Z-1458-2022 Class II — Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, (May 18, 2022)
  • Z-2488-2021 Class II — Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 (July 30, 2021)
  • Z-0662-2020 Class II — P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: La (September 28, 2018)
  • Z-2261-2018 Class II — P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthro (December 19, 2017)